Each tablet of Equagesic contains 200 mg meprobamate and 325 mg aspirin. The inactive ingredients present are cellulose, D&C Yellow 10, FD&C Red 3, FD&C Yellow 6, hydrogenated vegetable oil, magnesium stearate, polacrilin potassium, and starch.

Last updated on RxList: 12/8/2004

As an adjunct in the short-term treatment of pain accompanied by tension and/or anxiety in patients with musculoskeletal disease. Clinical trials have demonstrated that in these situations relief of pain is somewhat greater than with aspirin alone. The effectiveness of Equagesic in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient

The usual dosage of Equagesic is one or two tablets, each tablet containing meprobamate, 200 mg, and aspirin, 325 mg, orally 3 to 4 times daily as needed for the relief of pain when tension or anxiety is present. Equagesic is not recommended for patients 12 years of age and under.

Equagesic® (meprobamate with aspirin) Tablets, 200 mg meprobamate and 325 mg aspirin, are available as follows:

NDC 0008-0091, pink and yellow, double-layer, round, scored tablet marked "WYETH" and "91", in bottles of 100 tablets.

Store at room temperature, approx. 25^o C (77^o F). Keep tightly closed. Protect from light. Dispense in light-resistant, tight container.

Last updated on RxList: 12/8/2004

ASPIRIN

Aspirin may cause epigastric discomfort, nausea, and vomiting. Hypersensitivity reactions, including urticaria, angioneurotic edema, purpura, asthma, and anaphylaxis, may rarely occur. Patients receiving large doses of salicylates may develop tinnitus.

MEPROBAMATE

Central Nervous System

Drowsiness, ataxia, dizziness, slurred speech, headache, vertigo, weakness, paresthesias, impairment of visual accommodation, euphoria, overstimulation, paradoxical excitement, fast EEG activity.

Gastrointestinal

Nausea, vomiting, diarrhea.

Cardiovascular

Palpitation, tachycardia, various forms of arrhythmia, transient ECG changes, syncope, hypotensive crisis.

Allergic or Idiosyncratic

Milder reactions are characterized by an itchy, urticarial, or erythematous maculopapular rash which may be generalized or confined to the groin.

Other reactions have included leukopenia, acute nonthrombocytopenic purpura, petechiae, ecchymoses, eosinophilia, peripheral edema, adenopathy, fever, fixed-drug eruption with cross-reaction to carisoprodol, and cross-sensitivity between meprobamate/mebutamate and meprobamate/carbromal.

More severe hypersensitivity reactions, rarely reported, include hyperpyrexia, chills, angioneurotic edema, bronchospasm, oliguria, and anuria. Also, anaphylaxis, exfoliative dermatitis, stomatitis, and proctitis. Stevens-Johnson syndrome and bullous dermatitis have occurred.

Hematologic (see also Allergic or Idiosyncratic section above)

Agranulocytosis, aplastic anemia have been reported, although n o causal relationship has been established, and thrombocytopenic purpura.

Other

Exacerbation of porphyric symptoms.

No information provided.

Last updated on RxList: 12/8/2004

ASPIRIN

Salicylates should be used with extreme caution in patients with peptic ulcer, asthma, coagulation abnormalities, hypoprothrombinemia, vitamin K deficiency, or in those on anticoagulant therapy.

In rare instances, the use of aspirin in persons allergic to salicylates may result in life-threatening allergic episodes.

MEPROBAMATE

Drug Dependence

Physical dependence, psychological dependence, and abuse have occurred. Chronic intoxication from prolonged ingestion of, usually, greater-than-recommended doses is manifested by ataxia, slurred speech, and vertigo. Therefore, careful supervision of dose and amounts prescribed is advised, as well as avoidance of prolonged administration, especially for alcoholics and other patients with a known propensity for taking excessive quantities of drugs.

Sudden withdrawal of the drug after prolonged and excessive use may precipitate recurrence of preexisting symptoms, such as anxiety, anorexia, or insomnia, or withdrawal reactions, such as vomiting, ataxia, tremors, muscle twitching, confusional states, hallucinosis, and rarely, convulsive seizures. Such seizures are more likely to occur in persons with central-nervous-system damage or preexistent or latent convulsive disorders. Onset of withdrawal symptoms occurs usually within 12 to 48 hours after discontinuation of meprobamate; symptoms usually cease within the next 12- to 48- hour period. When excessive dosage has continued for weeks or months, dosage should be reduced gradually over a period of 1 to 2 weeks rather than abruptly stopped. Alternatively, a short- acting barbiturate may be substituted, then gradually withdrawn.

Potentially Hazardous Tasks

Patients should be warned that meprobamate may impair the mental or physical abilities required for performance of potentially hazardous tasks, such as driving or operating machinery.

Additive Effects

Since CNS- suppressant effects of meprobamate and alcohol or meprobamate and other psychotropic drugs may be additive, appropriate caution should be exercised with patients who take more than one of these agents simultaneously.

USAGE IN PREGNANCY AND LACTATION

An increased risk of congenital malformations associated with the use of minor tranquilizers (meprobamate, chiordiazepoxide, and diazepam) during the first trimester of pregnancy has been suggested in several studies. Because use of these drugs is rarely a matter of urgency, their use during this period should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug.

Meprobamate passes the placental barrier. it is present both in umbilical-cord blood at or near maternal plasma levels and in breast milk of lactating mothers at concentrations two to four times that of maternal plasma. When use of meprobamate is contemplated in breast-feeding patients, the drug's higher concentrations in breast milk as compared to maternal plasma levels should be considered.

USAGE IN CHILDREN

Preparations containing aspirin should be kept out of the reach of children. Equagesic is not recommended for patients 12 years of age and under.

ASPIRIN

Salicylates antagonize the uricosuric activity of probenecid and sulfinpyrazone. Salicylates are reported to enhance the hypoglycemic effect of the sulfonylurea antidiabetic drugs.

MEPROBAMATE

The lowest effective dose should be administered, particularly to elderly and/or debilitated patients, in order to preclude oversedation.

Meprobamate is metabolized in the liver and excreted by the kidney: to avoid its excess accumulation, caution should be exercised in the administration to patients with compromised liver or kidney function. Meprobamate occasionally may precipitate seizures in epileptic patients.

The drug should be prescribed cautiously and in small quantities to patients with suicidal tendencies.

Last updated on RxList: 12/8/2004

Treatment of overdose with Equagesic is essentially symptomatic and supportive. Any drug remaining in the stomach should be removed. Induction of vomiting or gastric lavage may be indicated.

Activated charcoal may reduce absorption of both aspirin and meprobamate.

Overdosage with aspirin produces the usual symptoms and signs of salicylate intoxication. Observation and treatment should include management of hyperthermia, specific parenteral electrolyte therapy for ketoacidosis and dehydration, watching for evidence of hemorrhagic manifestations due to hypoprothrombinemia which, if it occurs, usually requires whole-blood transfusions.

Suicidal attempts with meprobamate have resulted in drowsiness, lethargy, stupor, ataxia, coma, shock, vasomotor and respiratory collapse. Some suicidal attempts have been fatal.

The following data have been reported in the literature and from other sources. These data are not expected to correlate with each case (considering factors such as individual susceptibility and length of time from ingestion to treatment) but represent the usual ranges reported.

Acute simple overdose (meprobamate alone): Death has been reported with ingestion of as little as 12 grams meprobamate and survival with as much as 40 grams.

BLOOD LEVELS

0.5 to 2.0 mg percent represents the usual blood-level range of meprobamate after therapeutic doses. The level may occasionally be as high as 3.0 mg percent.

3 to 10 mg percent usually corresponds to findings of mild-to-moderate symptoms of overdosage, such as stupor or light coma.

10 to 20 mg percent usually corresponds to deeper coma, requiring more intensive treatment Some fatalities occur.

At levels greater than 20 mg percent, more fatalities than survivals can be expected.

Acute combined overdose (meprobamate with other psychotropic drugs or alcohol): Since effects can be additive, a history of ingestion of a low dose of meprobamate plus any of these compounds (or of a relatively low blood or tissue level) cannot be used as a prognostic indicator.

In cases where excessive doses have been taken, sleep ensues rapidly and blood pressure, pulse, and respiratory rates are reduced to basal levels. Any drug remaining in the stomach should be removed and symptomatic treatment given. Should respiration or blood pressure become compromised, respiratory assistance, central-nervous-system stimulants, and pressor agents should be administered cautiously as indicated. Diuresis, osmotic (mannitol) diuresis, peritoneal dialysis, and hemodialysis have been used successfully in removing both aspirin and meprobamate. Alkalinization of the urine increases the excretion of salicylates. Careful monitoring of urinary output is necessary, and caution should be taken to avoid overhydration. Relapse and death, after initial recovery, have been attributed to incomplete gastric emptying and delayed absorption.

ASPIRIN Allergic or idiosyncratic reactions to aspirin or related compounds.

MEPROBAMATE Acute intermittent porphyria and allergic or idiosyncratic reactions to meprobamate or related compounds, such as carisoprodol, mebutamate, or carbromal.

Last updated on RxList: 12/8/2004

Actions

Meprobamate is a carbamate derivative which has been shown (in animal and/or human studies) to have effects at multiple sites in the central nervous system, including the thalamus and limbic system. Aspirin, acetylsalicylic acid, is a nonnarcotic analgesic with antipyretic and anti-inflammatory properties.

Last updated on RxList: 12/8/2004

See WARNINGS, CONTRAINDICATIONS, and PRECAUTIONS.

Last updated on RxList: 12/8/2004

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

ASPIRIN/MEPROBAMATE - ORAL

(ASP-er-in/meh-PRO-buh-mate)

COMMON BRAND NAME(S): Equagesic, Micrainin

WARNING: This drug contains aspirin. Children and teenagers should not take aspirin if they have chickenpox, flu, or any undiagnosed illness without first consulting a doctor about Reye's syndrome, a rare but serious illness.

USES: This medication is used for short periods (usually no more than 10 days) along with other medications to treat muscle/bone pain problems that occur with tension and anxiety. This medication contains 2 drugs, aspirin and meprobamate. Aspirin is known as an analgesic and anti-inflammatory drug. It works by decreasing pain and swelling. Meprobamate is known as an anxiolytic. It works by affecting certain areas of the brain to help decrease symptoms of anxiety and nervousness. Together, these medications may provide better pain control than either alone.

HOW TO USE: Take this medication by mouth with or without food, usually 3-4 times daily as needed. Take exactly as prescribed by your doctor. Drink a full glass of water (8 ounces or 240 milliliters) with it unless your doctor tells you otherwise. Do not lie down for at least 30 minutes after taking this drug. If this medication causes stomach upset, take it with food or milk.

Dosage is based on your medical condition and response to treatment. This medication is usually taken as needed for pain/tension. If your pain/tension is severe, your doctor may direct you to take it regularly. In this case, to help you remember, take it at the same times each day. Do not take more or less of this medication than prescribed by your doctor. Doing so may increase pain/tension or side effects.

This medication may cause dependence, especially if it has been used regularly for an extended time or if it has been used in high doses. In such cases, withdrawal reactions (e.g., shakiness, confusion, nausea, vomiting, and rarely seizures) may occur if you suddenly stop taking this drug. To prevent withdrawal reactions when stopping extended, regular treatment with this drug, gradually reduce the dosage as directed. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

Though very unlikely, abnormal drug-seeking behavior (addiction) is possible with this medication. Do not increase your dose, take it more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed. When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.

Tell your doctor if your condition persists or worsens (e.g., your symptoms increase).

SIDE EFFECTS: See also Overdose section.

Drowsiness, dizziness, staggering, slurred speech, headache, nausea, vomiting, upset stomach, heartburn, and vision problems may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: easy bruising/bleeding, difficulty hearing, ringing in the ears, change in the amount of urine, signs of serious liver problems (e.g., persistent/severe nausea/vomiting, abdominal pain, unexplained tiredness, dark urine, yellowing of the eyes/skin), tingling/numbness in hands/feet, feeling unusually overactive, diarrhea.

This drug may rarely cause serious bleeding from the stomach/intestines or other areas of the body. If you notice any of the following unlikely but very serious side effects, seek immediate medical attention: black/tarry stools, persistent or severe stomach/abdominal pain, vomit that looks like coffee grounds, slurred speech, weakness on one side of the body, sudden vision changes, severe headache.

Tell your doctor if you notice any of the following rare but very serious side effects: fast/irregular heartbeat, fainting, swollen glands (lymph nodes), swollen hands/legs, signs of anemia (e.g., worsening tiredness, rapid breathing, pale skin, fast heartbeat while resting), signs of severe infection (e.g., high fever, severe chills, body aches, sore throat).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section.

Before taking aspirin/meprobamate, tell your doctor or pharmacist if you are allergic to it; or to other salicylates (e.g., choline salicylate), pain relievers, fever reducers (acetaminophen, NSAIDs such as ibuprofen, naproxen), carisoprodol, mebutamate, tybamate, carbromal; or to tartrazine dye; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain liver/blood problem (porphyria), aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), stomach ulcer, bleeding/blood-clotting disorders (e.g., hemophilia, vitamin K deficiency, low platelet count).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: mental/mood problems (e.g., severe depression, thoughts of suicide), brain damage, growths in the nose (nasal polyps), seizures, drug/alcohol abuse, kidney problems, liver disease, other stomach problems (e.g., previous stomach ulcer, heartburn, stomach pain), gout, diabetes, a certain hormone problem (Addison's disease), high pressure in the brain, head injury, untreated low thyroid (hypothyroidism), problems urinating (due to prostate enlargement), narrowing of the urethra.

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this product, may increase your risk for this side effect. Avoid alcoholic beverages, and stop smoking. Check with your doctor or pharmacist for more information. Before having surgery, tell your doctor or dentist that you are taking this medication.

This drug may make you dizzy or drowsy. Use caution while driving, using machinery, or doing any activity that requires alertness. Avoid alcoholic beverages because they may severely worsen dizziness and drowsiness.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially stomach bleeding, dizziness, and drowsiness.

This medication is not recommended for use during pregnancy. It may rarely harm an unborn baby. Consult your doctor for more details and to discuss reliable forms of birth control. If you become pregnant while taking this medication, tell your doctor immediately.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medications because very serious interactions may occur: sodium oxybate, ketorolac, mifepristone.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting aspirin/meprobamate.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: acetazolamide, "blood thinners" (e.g., warfarin, heparin), ticlopidine, NSAIDs (nonsteroidal anti-inflammatory drugs such as ibuprofen, naproxen), corticosteroids (e.g., prednisone), bisphosphonates taken by mouth (e.g., alendronate), certain medications for gout (e.g., probenecid, sulfinpyrazone), diabetes drugs (e.g., chlorpropamide, glyburide), anti-seizure drugs (e.g., phenytoin, valproic acid), high blood pressure drugs (e.g., ACE inhibitors such as captopril, beta blockers such as metoprolol), SSRI antidepressants (e.g., fluoxetine, sertraline), "water pills" (diuretics such as furosemide, spironolactone), pemetrexed, methotrexate, 6-mercaptopurine, herbal medications such as ginkgo biloba.

If your child/adolescent is using this product, consult your doctor if they have recently received certain live vaccines (e.g., varicella vaccine, live flu vaccine).

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, clonazepam, diazepam, zolpidem), muscle relaxants (e.g., methocarbamol), narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone).

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Check all prescription and nonprescription medicine labels carefully since many medications also contain pain relievers known as NSAIDs (nonsteroidal anti-inflammatory drugs such as ibuprofen, naproxen). Using these medications with aspirin/meprobamate may increase the possibility of stomach bleeding/ulcers.

To prevent an overdose of aspirin, read the labels carefully before taking other pain relievers or cold products to make sure they do not contain aspirin. Ask your pharmacist about using these products safely.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: burning pain in the throat/stomach, confusion, severe drowsiness, severe staggering when walking, slurred speech, mental/mood changes (e.g., agitation), weakness, ringing in the ears, high fever, rapid breathing, change in the amount of urine, seizures, loss of consciousness, very slowed breathing.

NOTES: Do not share this medication with others. It is against the law.

Keep all medical appointments. Your doctor will periodically monitor your progress or check for side effects. Consult your doctor for more details.

This medication may interfere with certain laboratory tests, including certain urine tests (e.g., sugar, uric acid among others), certain blood tests (e.g., BUN, cholesterol, liver tests, bleeding time among others), possibly causing false test results. Make sure laboratory personnel and all your doctors know you are taking this medication.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.